The
U.S. Response to the BW Threat; Legislation and Strategy

Several events
lead to the decision by the U.S. to devote more resources to civilian biodefense.
Discussions began around 1995 following public disclosure of the BW program
conducted by the Aum
Shinrikyo cult between 1990 and 1994 and following its release of sarin gas in a
Tokyo subway. President
Clinton’s interest in science and technology was instrumental in encouraging
the government to consider what should be done to prepare the U.S. for a
potential BW or chemical weapons release. Sometime during 1997 President Clinton
and the Secretary of Defense (William S. Cohan) became even more concerned of
the possibility of a nonstate actor’s BW attack after they read a fictional
novel on the subject. In the fall of 1997 the Department of Defense appropriated
$10 million to define the role of the National Guard in the fight against
chemical or biological terrorism. On April 10, 1998 President Clinton met with
several scientists and discussed bioterrorism. From that discussion they
developed a set of recommendations that would better prepare the country for a
bioterrorist attack. Those recommendations called for $1.9 billion dollars over
a five-year time period (20, 40).

On May 22, 1998,
President Clinton issued Presidential Decision Directive/NSC-63. His intent in
this directive was to, “…assure the continuity and viability of critical
infrastructures. I intend that the United States will take all necessary
measures to swiftly eliminate any significant vulnerability to both physical and
cyber attacks on our critical infrastructures, including especially our cyber
systems.” The directive’s national goal was, by 2003, to develop and
maintain the ability to protect the U.S. critical infrastructures from
intentional acts that would significantly damage the abilities of the federal
(national security, public health and safety), state (maintain order and
essential public services), and local governments (maintain order and essential
public services) and of the private sector (orderly economic functioning,
deliver essential telecommunications, energy, financial and transportation
services) (41). Twenty-three federal government agencies were instructed to
develop plans to ensure continuation of essential government services during
national emergencies. As of spring 2004 none of these agencies had fully
complied and developed adequate plans. (42)

The nonstate actor
attacks of September 11th, 2001 on the World Trade Centers in New
York City and the anthrax-by-mail releases later that same month made the nation
acutely aware of its vulnerability to attack. Before these events most of the
attention in the biodefense industry was devoted to protecting military
personnel. Since these events an enormous amount of resources have been devoted
to civilian biodefense programs. In 2000 to 2002 several legislative initiatives
were started and included the Public Health Improvement Act of 2000, the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002 and the
Homeland Security Act of 2002 (30).

On November 13 of 2000 the Public Health Improvement Act was signed into law.
It included Title I the, “Public Health Threats and
Emergencies Act.” This act was established to provide grants to state and
local governments to help them prepare for public health emergencies, including
emergencies resulting from acts of bioterrorism. This act empowers the Health
and Human Services (HHS) Secretary to in consultation with the CDC Director and
other public health officials to take appropriate actions if, “a disease or
disorder presents a public health emergency; or (2) a public health emergency,
including significant outbreaks of infectious diseases or bioterrorist attacks,
otherwise exists.” These “appropriate” actions include: “making grants
and entering into contracts and conducting and supporting investigations into
the cause, treatment, or prevention of a disease or disorder.” Title I of this
act also provides funds to established a, “Public Health Emergency Fund" (43).

This fund allows the HHS Secretary to carry out appropriate actions if a
public health emergency is declared. It also includes funds to improve state and
local public health agencies, establishes an antimicrobial resistance task
force, gives the HHS Secretary oversight on research and development of
bioterrorist attack countermeasures as well as new antimicrobial drugs and
diagnostics. Lastly it directs the, “HHS Secretary in coordination with the Department
of Defense, to establish an interdepartmental working group on
preparedness and readiness for the medical and public health effects of a
bioterrorist attack on the civilian population.” The funds given to state and
local governments to strengthen their public health infrastructure from
September 11, 2001 to June 2004 was over $3.7 billion (43).

The Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 contained
provisions to enhance state and local bioterrorism response capabilities,
improve management of the stockpile of bioterrorism medical countermeasures
(vaccines, antisera, and antibiotics), toughen control of biological agents and
strengthen protections on food and water. Near the end of 2002 the federal
government in the Homeland Security Act of 2002 created the Department of
Homeland Security (DHS). The DHS was assigned significant biodefense
responsibilities. (30)

Another objective
of the homeland security agenda for biodefense since 2001 has been the addition
of existing medical products to the Strategic National Stockpile. This stockpile
was started in 1999. It contains stores of antibiotics, vaccines and other
medical countermeasures (also includes supplies for chemical and radiological
incidents). The stockpile contains a dozen 12-Hour Push Packs, which contain 50
tons of medical supplies. These Push Packs are prepackaged so that aircraft or
tractor-trailers can deliver them immediately. The stockpile also contains
Vendor Managed Inventories of certain key products that commercial suppliers
maintain for the government in the event of a catastrophic attack. Antibiotics
were the initial focus of the stockpile but it now also has millions of doses of
smallpox vaccine (30).

The Department of
Human Services 2004 budget included $400 million to maintain the stockpile and
nearly $900 million to acquire new medical countermeasures. Two key deficiencies
undermine potential success of the stockpile during a biodefense emergency.
First, the effectiveness of the stockpile depends on the ability of state and
local governments to distribute the Push Packs contents following delivery.
Exercises in 2001 demonstrated that many state and local governments were not
prepared to deliver the medical supplies and countermeasures. Even though states
and local governments have obtained funding to better their response times the
level of preparedness is highly variable. Second, the stockpile does not contain
medical countermeasures for some BW and the countermeasures available for other
BW are less than adequate.

Knowing the U.S.
lacked many adequate BW countermeasures President Bush in his January 2003
State of the Union speech announced the beginning of an initiative called
Project BioShield. It is hoped that this initiative will enhance the
government’s ability to develop and acquire medical countermeasures. The
National Institute of Allergies and Infectious Diseases (NIAID) an institute
within the National Institutes of Health (NIH) has the primary responsibility
for developing new medical countermeasures. The strategic plan developed by the
NIAID calls for development of new vaccines, therapeutics, adjuvants and
immunostimulants and diagnostics for rapid identification of BW. The fiscal year
2004 budget included $3 billion for biodefense medical countermeasures (30).

In July 2003, the
DHS, EPA and CDC began “Biowatch” a thirty-one-city program to monitor for
BW agents in the air. Biowatch involves the use of five hundred air filters that
are collected every twelve hours. The filter contents are then analyzed for BW
agents using genetic-based detection equipment. This is an example of an attempt
to create a sensor web in which BW detectors are distributed across the country.
(44)

From 1998 to 2004
biodefense funding increased dramatically. In 1999 there was little funding for
biodefense. Around $1.4 billion was allocated for biodefense in 2001. However,
in 2002 funding of biodefense nearly quadrupled ($5.9 billion). Bush’s 2003
homeland defense budget included defense against bioterrorism as one of its four
key initiatives (30). By 2004 the funding for civilian
biodefense grew to $11.9 billion. (39, 40)

In a White House
statement by George W. Bush on December 11, 2002 the President discussed a
threefold strategy (13) to improve national security concerning weapons of mass
destruction (WMD) like BW. He said, “Our national strategy to combat WMD is
based on three pillars. We will pursue robust counterproliferation policies and
capabilities to deter and defend against the use of these weapons. We will
strengthen nonproliferation measures to prevent states and terrorists from
acquiring WMD. We will increase our preparations to respond effectively to any
use of WMD against us or our friends and allies. To succeed, we must use new
technologies, strengthen our intelligence capabilities, work even more closely
with allies, and establish new partnerships with other key states, including
former adversaries.” (45).